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the Effect of Acupuncture on the Quality of Oocyte on Poor Ovarian Response(POR) (POR)

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ClinicalTrials.gov Identifier: NCT03994614
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

Brief Summary:
Patients in experimental group will be given acupuncture treatment for 12 weeks prior to controlled ovarian stimulation (COS).The patients will be given three times acupuncture every week except menstruation.Patients in no intervention group will not be given any intervention for 12 weeks prior to COS. The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes.

Condition or disease Intervention/treatment Phase
Poor Ovarian Response Other: acupuncture Not Applicable

Detailed Description:

The patients will be randomly recruited into two groups. Patients in experimental group will be given acupuncture treatment for 12 weeks prior to COS.The patients will be given three times acupuncture every week except menstruation. One treatment lasts for 30 minutes. The acupuncture acupoint locations are as follows: head acupoint(Yintang, Shenting, Baihui), abdominal acupoint (Guanyuan, Zhongji), leg acupoint(Sanyinjiao, Zusanli),waist acupoint (Shenyu, Guanyuanyu). Patients in no intervention group will not be given any intervention for 12 weeks prior to COS.

When at least one dominant follicle is greater than 18 mm then injection Human chorionic gonadotropin (hCG) 10000 IU. 36 hours later transvaginal oocyte retrieval will be taken. After 3 hours of incubation, each egg will be transferred with a density of about 100,000/mllive sperm. The fresh embryo transfer is performed 72 hours after embryo culture in vitro. The whole embryos will be frozen.

The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes,including basic endocrine, serum Anti-Mullerian Hormone (AMH), gonadotropin (Gn) dosage and duration, estrogen level on HCG day, number of eggs obtained, fertilization rate, cleavage rate, effective embryo rate, cycle cancellation rate, the clinical pregnancy rate.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Trial of the Effect of Acupuncture on the Quality of the Oocyte on Poor Ovarian Response
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: the Acupuncture intervention group
Patients in this group will be given acupuncture treatment for 12 weeks prior to COS.
Other: acupuncture
Patients in the experimental group will be given acupuncture treatment for 12 weeks prior to COS. The patients will be given three times acupuncture every week except menstruation. The acupuncture acupoint locations are as follows: head acupoint(Yintang, Shenting, Baihui), abdominal acupoint (Guanyuan, Zhongji), leg acupoint(Sanyinjiao, Zusanli),waist acupoint (Shenyu, Guanyuanyu)

No Intervention: No intervention group
Patients in this group will not be given any intervention for 12 weeks prior to COS.



Primary Outcome Measures :
  1. The number of MII eggs [ Time Frame: one day after oocyte pickup ]
    The number of MII eggs obtained in the COS cycle


Secondary Outcome Measures :
  1. Basic Follicle stimulating hormone (FSH) value [ Time Frame: On Day two of menstruation ]
    Basic FSH value in mIU/ml

  2. Basic Luteinizing hormone (LH) value [ Time Frame: On Day two of menstruation ]
    Basic LH in mIU/ml

  3. Basic estrodiol value [ Time Frame: On Day two of menstruation ]
    Basic estrodiol in pg/ml

  4. Serum AMH value [ Time Frame: On Day two of menstruation ]
    Serum AMH in ng/ml

  5. estrogen level [ Time Frame: estrogen level on HCG day ]
    estrogen level on HCG day in pg/ml

  6. the number of embryo [ Time Frame: On the day 5-6 after oocyte pickup ]
    the number of embryo obtained in the COS cycle



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The poor ovarian response patients compliance with Bologna consensus
  2. Age:20-45 year

Exclusion Criteria:

  1. Her husband is oligoasthenospermia
  2. Patients with genital tract malformation. Uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus)
  3. Complicated with medical diseases(Hypertension, diabetes, psychosis, hereditary diseases)
  4. Refusal to sign the informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994614


Contacts
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Contact: Wenbi Zhang, doctor +8618616860905 jackeyzhang0905@163.com

Sponsors and Collaborators
ShangHai Ji Ai Genetics & IVF Institute
Investigators
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Principal Investigator: Wenbi Zhang, doctor Fudan University

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Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT03994614     History of Changes
Other Study ID Numbers: JIAI 2019-4
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ShangHai Ji Ai Genetics & IVF Institute:
acupuncture
quality
oocyte
poor ovarian response